Clinical validation of the cobas 4800 HPV test for cervical screening purposes.
نویسندگان
چکیده
This study shows that the clinical performance and reproducibility of the cobas 4800 HPV test for high-risk human papillomavirus (HPV) detection fulfill the criteria as formulated in international guidelines of HPV test requirements for cervical screening purposes. Accordingly, the cobas 4800 HPV test can be considered clinically validated for cervical screening.
منابع مشابه
Evaluation of the Cobas 4800 HPV Test for Detecting High-Risk Human Papilloma-Virus in Cervical Cytology Specimens
As new platforms for high-risk strains of human papillomavirus (HR HPV) testing are introduced into the clinical laboratory, it is important to verify their performance and agreement. In this validation study, post-aliquot cervical cytopathology specimens (n = 226) were used to analyze agreement between the Invader HPV ASR assay (Hologic) and the recently FDA-approved Cobas 4800 high-risk HPV a...
متن کاملHigh-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study.
This study evaluated the clinical performance of the cobas 4800 HPV Test (Roche Molecular Systems, Pleasanton, CA) for high-risk human papillomavirus (HR-HPV) testing with individual HPV-16/HPV-18 genotyping in women 21 years or older with atypical squamous cells of undetermined significance (ASC-US). Women (N = 47,208) were recruited in the United States during routine screening, and liquid-ba...
متن کاملComparison of the Cobas 4800 HPV Test and the Seeplex HPV4A ACE with the Hybrid Capture 2 Test
BACKGROUND It is well-known that persistent cervical infections with high-risk human papillomavirus (HPV) are related to the development of high-grade cervical intraepithelial neoplasia and invasive cervical cancer and that infection with HPV 16 and HPV 18 accounts for approximately 70% of all cases of invasive cervical cancer. METHODS We performed 3 HPV molecular tests-the Cobas 4800 HPV tes...
متن کاملComparison of the Cobas 4800 HPV and HPV 9G DNA Chip Tests for Detection of High-Risk Human Papillomavirus in Cervical Specimens of Women with Consecutive Positive HPV Tests But Negative Pap Smears
Detecting high-risk (HR) HPV is important for clinical management of women with persistent HPV-positive and Pap-negative results. The Cobas 4800 HPV test is the first FDA-approved HPV DNA test that can be used alone as a first-line screening tool. The HPV 9G DNA chip test is a PCR-based DNA microarray assay. We evaluated the patients of consecutive HPV-positivity on HPV 9G DNA chip test without...
متن کاملSputasol (Dithiothreitol 0.54%) Improves the Detection of Human Papillomaviruses Using the Cobas 4800 System
Dear Editor, Persistent infection with human papillomavirus (HPV) is the main cause of cervical cancer. Screening of cervical specimens for high-risk human papillomaviruses (HR-HPV) has become a routine part of patient care in most countries. The Roche cobas 4800 system (Roche Molecular Systems Inc., Pleasanton, CA, USA), a fully automated system that uses in vitro qualitative realtime PCR tech...
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ورودعنوان ژورنال:
- Journal of clinical microbiology
دوره 49 11 شماره
صفحات -
تاریخ انتشار 2011